The Recall Desk

FDA (Devices) recall action 37654

General Electric Med Systems LLC recalled 3 products on 2012-06-20

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-06-20
Critical
0
Units
11,388

Why these products were recalled

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2012-06-20

    GE Healthcare Revolution XR/d Recalled for Finger Pinch Hazard

    General Electric is recalling 3,796 Revolution XR/d digital radiographic imaging systems worldwide due to a reported incident where an operator's finger was pinched.

    Product
    GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to…
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    0 states
  • HighFDA (Devices)··2012-06-20

    GE Healthcare Definium 8000 Digital Radiographic Systems Recalled for Pinch Hazard

    General Electric is recalling 3,796 Definium 8000 Digital Radiographic Systems because an operator's finger was pinched between the fixed roller and the gliding tabletop.

    Product
    GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for…
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    0 states
  • HighFDA (Devices)··2012-06-20

    GE Proteus XR/a Radiographic System Recalled Due to Pinch Hazard

    General Electric is recalling 3,796 Proteus XR/a Radiographic Systems worldwide because an operator's finger was pinched between the fixed roller and the gliding tabletop.

    Product
    GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic…
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    0 states